Drug product
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05.
D-0999-2019
Product summary
- Event
- Event 82102
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,950 54 mL bags
- Official record key
drug-enforcement:D-0999-2019
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Code information: 138-20182509@110, 138-20182509@111; 138-20182509@112, BUD 12/24/2018; 138-20180210@76, 138-20180210@86, BUD 12/31/2018; 138-20180410@66, BUD 1/2/2019; 138-20183110@43, 138-20183110@44, BUD 1/29/2019; 138-20180111@84, 138-20180111@85, BUD 1/30/2019; 138-20180611@36, 138-20180611@39, 138-20180611@52, 138-20180611@60, BUD 2/4/2019; 138-20181911@125; 138-20181911@126, BUD 2/17/2019; 138-20182011@56, BUD 2/18/2019.
Distribution pattern: Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing